NCT05235646

Brief Summary

The purpose of this research is to develop machine learning algorithms to analyze images from brain MRI to confirm that contrast agent has been correctly administered.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 19, 2022

Completed
23 days until next milestone

First Posted

Study publicly available on registry

February 11, 2022

Completed
1 month until next milestone

Study Start

First participant enrolled

March 14, 2022

Completed
22 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 5, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 5, 2022

Completed
Last Updated

April 11, 2022

Status Verified

April 1, 2022

Enrollment Period

22 days

First QC Date

January 19, 2022

Last Update Submit

April 8, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • Detection of Infiltration of Gadolinium contrast agent into tissue and muscle using artificial intelligence model

    Correct detection of the presence of infiltration of Gadolinium contrast agent into tissue and muscleusing an artificial intelligence model. This outcome will be determined by measuring the difference in signal enhancement in the nasal mucosa or the lack of signal enhancement within the nasal mucosa.

    2 months

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adults undergoing MR brain without and with IV contrast examination as part of their care plan.

You may qualify if:

  • Patients undergoing a MR brain without and with contrast examination on any GE or Siemens 1.5T and 3T MRI system within Mayo Clinic, Rochester, as part of their care plan.

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic Rochester

Rochester, Minnesota, 55905, United States

Location

Related Links

Study Officials

  • James Pipe, PhD

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 19, 2022

First Posted

February 11, 2022

Study Start

March 14, 2022

Primary Completion

April 5, 2022

Study Completion

April 5, 2022

Last Updated

April 11, 2022

Record last verified: 2022-04

Locations